Effects of Routine Physical Therapy With and Without Proprioceptive Neuromuscular Facilitation on Balance, Gait and Function in Patients With Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

Effects of Routine Physical Therapy With and Without Proprioceptive Neuromuscular Facilitation on Balance, Gait and Function in Patients With Parkinson's Disease.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05154552
• Other study ID #: IRB-UOL-FAHS/986/2021
• Status: Completed
• Phase: N/A
• Start date: November 5, 2021
• Est. completion date: March 3, 2022

Study information

• Verified date: March 2022
• Source: University of Lahore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Objective of this study is to compare the effectiveness of routine physical therapy with and without Proprioceptive Neuromuscular Facilitation on Balance, gait and function in patients with Parkinson's disease.

Alternate hypothesis:

There will be a difference in the effects of routine physical therapy with and without proprioceptive neuromuscular facilitation on balance, gait and function in patients with Parkinson's disease.

Null hypothesis:

There will be no difference in the effects of routine physical therapy with and without proprioceptive neuromuscular facilitation on balance, gait and function in patients with Parkinson's disease.

Description:

It will be a prospectively registered, parallel designed, single blinded randomized controlled trial with concealed allocation, conducted in University of Lahore Teaching Hospital and Sir Ganga Raam hospital, Lahore, Pakistan. Patients who met eligibility criteria will be informed about the aim of study.consent form will be signed by all eligible participants. Eligibility of participants will be confirmed by the physiotherapist of research team before randomization. After baseline assessment, eligible patients will be randomly allocated(in a 1:! ratio) in two groups( group A and group B). Fish bowl method of randomization will be used and will be done by one of the research team members who will not involve in patient recruitment or assessment or data analysis.

Randomization assignments will be kept in opaque, sealed envelopes for concealment of group allocation and will be unsealed by researcher after baseline testing. Researchers who assess outcomes or will do data analyses will be masked to group allocation.The calculated sample size is 32 (16 in each group), after adding 20% dropout the sample size will be 32+6=38, 19 patients in each group.(statistical power 80% and alpha level of 5%).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: March 3, 2022
• Est. primary completion date: March 3, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 85 Years

Eligibility

Inclusion Criteria:

• Male and female patients of age between 60 and 85 years, diagnosed with Parkinson's disease by a neurologist.

• Patients with Hoehn and Yahr stages 1-3.

• Patients with a stable drug program and acclimated to their current medication use for at least 2 weeks.

Exclusion Criteria:

• Cognitive deficits (scores of <26 on the Mini-Mental State Examination).

• Moderate or severe depression (scores of >17 on the Beck Depression Inventory).

• Patients with neurological diseases, arthrosis, or total hip joint replacement.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Other:
• Proprioceptive Neuromuscular Facilitation
Proprioceptive Neuromuscular Facilitation (PNF) is a more advanced form of flexibility training, which involves both the stretching and contracting of the muscle group being targeted. PNF stretching is one of the most effective forms of stretching for improving flexibility and increasing range of motion.
• Routine physical therapy
Routine physiotherapy in Parkinson Disease will be administered according to the European Physiotherapy guidelines for Parkinson Disease and focused on the following areas based on the stage of the disease:Self-management support, prevention of inactivity and fear of falls, maintaining or improving global motor activities, improvement of physical performance, and improvement in the ability to perform transfer, balance, gait, and manual activities, reduce pain, and delay the onset of physical limitations. Other exercises include: Range of motion exercises Stretching exercises Upper and lower limb strengthening exercises

Locations

Country	Name	City	State
Pakistan	Sir Ganga Raam Hospital	Lahore	Punjab
Pakistan	University of Lahore Teaching Hospital	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
University of Lahore

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Berg balance scale (BBS) (to access the change in ability to balance in individuals at baseline, 6th and 12th week of interventions.)	It is used to objectively determine a patient's ability or inability to safely balance during a series of predetermined tasks. It consist of a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4.0 denotes inability to complete the item, and 4 the ability to accomplish the task. Scores of less than 45 out of 56 are accepted as indicative of balance disorders in the elderly.	the change in ability to balance in individuals at baseline, 6th and 12th week of interventions.
Primary	The Freezing of Gait Questionnaire (FOGQ) (to access the change in freezing of gait in individuals at baseline, 6th and 12th week.)	It is used to assess freezing of gait severity in patients with Parkinson's disease. It consists of a 6-item questionnaire. A 5-point scale is used to mark scores. Zero (absence of symptoms) to 4 (most severe), is used for each item to rank severity of symptoms.	the change in freezing of gait in individuals at baseline, 6th and 12th week
Primary	Functional Independence Measure (FIM) (to assess the change in ability to do activities of daily living at baseline, 6th and 12th week.)	It is used to assess the ability of patients to do activities of daily living. It consist of 18-item, clinician-reported scale that assesses function in six areas including self-care, continence, mobility, transfers, communication, and cognition. Total score for FIM will be a value between 18 and 126. Higher the score, more independent the patient is.	the change in ability to do activities of daily living at baseline, 6th and 12th week